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GeneProof Factor V Leiden MC PCR Kit

CE IVD myCROBE® line

On this page you will find order codestechnical specifications and documents for the selected product.

Order information

Product name Catalog no. Technology Packaging
GeneProof Factor V Leiden MC PCR Kit FV/MC/200 PCR for 180 tests

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status  CE IVD / EC Directive 98/79/EC
Intended User For professional use in laboratories with trained staff
Test Principle Real-time polymerase chain reaction (PCR)
Type of Analysis Qualitative
Automated / Manual detection Automated
Target G1691A Polymorphism in the F5 gene of Factor V Leiden (rs6025)
Specificity Single nucleotide guanine/adenine polymorphism in the F5 gene of Factor V Leiden in site 1691 (rs6025)
Concentration Range 10-90 ng/µl
Negative Percentage Agreement 100% (CI95%: 97.04% - 100%)
Positive Percentage Agreement 100% (CI95%: 79.08% - 100%)
Overall Percentage Agreement 100% (CI95%: 97.35% - 100%)
Validated Specimen Whole blood
Validated Extraction Methods myCROBE/croBEE 2.0 Universal Extraction Kit
Instruments

myCROBE® Fully Automated Instrument

Detection Channels FAM, HEX
External Quality Assessment Regularly tested in INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com

Documentation

Instruction for Use

; GP_MC_FV_Instruction_for_Use_EN
pdf, [144.19 kB]

Declaration of Conformity

; GP_MC_FV_Declaration_of_Conformity_EN
pdf, [598.61 kB]

MSDS

; GP_MC_FV_Safety_Data_Sheet_EN
pdf, [273.91 kB]
Files are available only for registered users.

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